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U.S. Department of Health and Human Services

Class 2 Device Recall Fabius Trio Gas machine

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 Class 2 Recall
Fabius Trio Gas machine
see related information
Date Posted September 23, 2008
Recall Status1 Terminated on March 08, 2010
Recall Number Z-2338-2008
Recall Event ID 48979
Premarket Notification
510(K) Number
K042419 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.
Code Information Serial numbers: ARYA-xxxx, ARYB-xxxx, ARYC-xxxx, ARYD-xxxx, ARYE-xxxx, ARYF-xxxx, ARYH-xxxx, ARYJ-xxxx, ARYK-xxxx, ARYL-xxxx, ARYM-xxxx,ARYN-xxxx, ARZA-xxxx ARZB-xxxx (where xxxx represents any 4 digit number)
Recalling Firm/
Manufacturer
Draeger Medical, Inc.
3135 Quarry Rd
Telford, Pennsylvania 18969-1042
For Additional Information Contact Drager Service Technical Support
800-543-5047
Manufacturer Reason
for Recall
The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.
Quantity in Commerce 111 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DRAEGER MEDICAL, INC.
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